Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/16/2013 |
| Start Date: | July 2012 |
| End Date: | July 2019 |
| Contact: | Epp Goodwin |
| Email: | onctrial@idd.org |
| Phone: | 210-450-5798 |
Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies
Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery
followed by postoperative radiation therapy. Studies have shown the superiority of combined
modality therapy compared to surgery alone. Despite the addition of postoperative radiation
therapy, the five-year survival for locally advanced salivary gland malignancies is poor
(less than 60%). In salivary gland malignancies, the epidermal growth factor receptor (EGFR)
is expressed in 25-85%; in certain histological types, like salivary duct carcinomas, the
expression is higher. EGFR is a promising target of anticancer therapy. In squamous cell
carcinoma of the head and neck, a phase III trial utilizing cetuximab added to radiation
therapy improved both locoregional control and overall survival compared to radiation alone.
Panitumumab is a novel, human, IgG2 EGFR monoclonal antibody that may be better tolerated
and more efficacious than cetuximab. Here, the investigators hypothesize that the addition
of panitumumab to standard radiotherapy in locally advanced salivary gland malignancies will
improve recurrence-free survival (RFS).
Specific Aims To determine the recurrence-free survival (primary endpoint), overall
survival, local and distant recurrence-free survival, and treatment-related toxicities.
Also, the investigators plan to study EGFR-related and immune biomarkers in baseline tumor
tissue as well as blood samples obtained prior and after therapy.
Subject Population We will enroll patients with completely resected, locally advanced
salivary gland cancers.
Treatment Plan Standard radiation 64-70Gy with 2.0 Gy daily fractions in 6-7 weeks.
Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-7 doses).
Statistical Design and Sample Size Phase II, one-stage, study with the 3-year
recurrence-free survival (RFS) as the primary endpoint. The sample size is 30 patients.
Inclusion Criteria:
- Pathologically determined salivary gland cancer of the major or minor salivary glands
of the head and neck (any histology) status post potentially curative surgical
resection with no macroscopic residual disease. Patients should have AJCC 6th edition
stage III with 1) extracapsular extension, 2) perineural invasion, 3) positive
surgical margins or 4) high grade histology or stage IVA or IVB.
- No distant metastasis.
- No prior chemotherapy, biological-targeted therapy (including any prior therapy which
specifically and directly targets the EGFR pathway), or radiotherapy for head and
neck cancer.
- No more than 10 weeks (minimum of 3 weeks) should elapse between surgery and
treatment on study.
- ECOG performance status of 0-2.
- Patients must have normal organ and marrow function.
- No prior invasive malignancy unless the disease-free survival is 3 years or more.
- Age 18+ years.
- Pregnant or breast-feeding women are excluded (see exclusion criteria).
- Informed consent must be obtained fkom all patients prior to beginning research
related treatment.
- Patients should have the ability to understand and the willingness to sign a written
informed consent document.
Exclusion Criteria:
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months) uncontrolled
congestive heart failure, and cardiomyopathy with decreased ejection fraction. All
patients will have a baseline EKG. If abnormalities consistent with active coronary
artery disease are detected, the patient will be referred to a cardiologist for
appropriate evaluation and management prior to treatment on study.
- Patients may not be receiving any other investigational agents.
- No history of prior malignancy, with the exception of basal carcinoma of the skin or
in situ cervical cancer, or malignancy that has been treated with a curative intent
with a 3-year disease-free survival.
- Pregnant women are excluded from this study because chemotherapy and radiation
therapy have the potential for teratogenic or abortifacient effects.
- Prior severe ifision reaction to a human monoclonal antibody.
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